Technical information systems, safety requirements

The guarantee of conformity to the essential requirements of the MDD is provided by the interaction between the manufacturer and a third party, the notified body. The notified bodies are organizations that are recognized by the member states to conduct device evaluations and inspections of the quality systems of the various manufacturers. The manufacturers are held responsible for the quality, safety, and effectiveness of their medical devices. This is enforced through the manufacturer s written declaration of conformity and commitment to keep all technical information available for inspection by the notified bodies and national authorities. 

To achieve the first two aspects, the system engineer and safety practitioner will need to obtain technical information from the ETSO holder on the behaviour of their component. Whilst software requirements specifications and design descriptions are rarely available (due to intellectual property constraints), the integrator should at least be able to access the technical data on integration and the operator manuals in order to discern the behaviors of the system. Remember though, the focus should not just be the functional behaviors but also the behavior of the system under failure conditions. ... 

DOE 1997), This order requires a system for reporting of operations information on unusual occurrences. Section 7, "Occurrence Categorization, Notification, and Reporting Requirements," Part (2) defines a violation of a technical safety requirement as an Unusual Occurrence, which requires DOE notification Mthin two hours of categorization (i.e., identification of the occurrence as an Unusual Occurrence), followed by written notification within 24 hours utilizing a Notification Report. 

The discussion of the complete flow of information goes far beyond the scope of this chapter. Therefore, we will focus on discussing selected illustrative examples Customer and regulation bodies will provide requirements for the product and the production system to the plant owner. The customers will define the product characteristics (e.g., product type and quality, amount) resulting in the definition of the production process to be executed on the production system. The regulation bodies will define safety-related product requirements (like CE conformity) and production system-related safety and workforce requirements (like protection guidelines from the employers mutual insurance associations). All these kinds of information are related to function-related information or further technical information. 

Gather the requirements for the systems including functional (e.g. operational checks) requirements, nonfunctional (e.g., coding standards) requirements, users, company-wide regulatory compliance (e.g., Part 11 technical control), safety, process, and other applicable requirements Characterize information, assess its value to the organization, and incorporate information quality as part of the project plan Conduct a system (hardware, software, and process) risk analysis. New requirements may be found as the result of the risk analysis. Any new requirements must be documented in the requirements specification deliverable... 

After the Three Mile Island accident the USNRC issued requirements for installation of safety parameter display systems (SPDS) to ensure that control room operators had ready access to key information under accident conditions. This information is also commonly displayed in the plant technical support centre. 

All the design requirements on SSCs associated with safety during normal operation that are identified through the application of this process are presented in Chapters 6 and 7 of this PCSR, accompanied by substantiation statements, which refer to more detailed design information in APIOOO technical documentation. Chapter 6 of the PCSR identifies all design requirements associated with safety during normal operation for each system in turn, and Chapter 7 covers those associated with civil works and stmctures. 

The ontology of Safety-II is consistent with the fact that many socio-technical systems have become so complicated that work situations are always underspecified, hence partially unpredictable. Because most socio-technical systems are intractable, work conditions will nearly always differ from what has been specified or prescribed. This means that little, if anything, can be done unless work - tasks and tools - are adjusted so that they correspond to the situation. Performance variability is not only normal and necessary but also indispensable. The adjustments are made by people individually and collectively, as well as by the organisation itself. Everyone, from bottom to top, must adjust what they do to meet existing conditions (resources and requirements). Because the resources of work (time, information, materials, equipment, the presence and availability of other people) are finite, such adjustments will always be approximate rather than perfect. The approximation means that there is inevitably a small discrepancy between what ideally should have been done, or the perfect adjustment, and what is actually done. Yet the discrepancy is usually so small that it has no negative consequences or can be compensated for by downstream adjustments. This is so regardless of whether the discrepancy is found in one s own work or in the work of others. 

As technical and socio-technical systems have continued to develop, not least due to the allure of ever more powerful information technology, systems and work environments have gradually become more intractable (Chapter 6). Since the models and methods of Safety-I assume that systems are tractable in the sense that they are well understood and well behaved, Safety-I models and methods are less and less able to deliver the required and coveted state of safety. Because this inability cannot be... 

It is very likely that if technical systems are to be included in part of the audit process that appropriate qualified engineers may be required to provide additional information on fire safety systems. 

---